GlaxoSmithKline terminates Crohn's drug program following a pivotal failure

When ChemoCentryx ($CCXI) reported last month that its Crohn's disease drug vercirnon (GSK1605786) failedthe first of four Phase III trials mounted by GlaxoSmithKline ($GSK), the biotech said it was awaiting word from the pharma giant on its future development plans.

That decision has come down now. Referring to a slate of updates on Sept. 12, Clinicaltrials.gov now lists the other three Phase III trials--SHIELD-2, 3 and 4--as terminated. And a spokesperson for GlaxoSmithKline confirmed to FierceBiotech that the studies were axed.

"Those studies have been terminated," says Glaxo spokesperson Melinda Stubbee in an email to FierceBiotech. "No efficacy was observed with either dose of vercirnon over 12 weeks in SHIELD-1. In addition, dose-dependent increases in rates of adverse events (AEs), gastrointestinal AEs, and cardiac AEs, including two cardiac serious AEs in the 500mg twice daily group, were observed. Those findings have reduced the benefit to risk profile of vercirnon and don't support the continued treatment of the study patients."

Three weeks ago the biotech reported that "new recruitment and dosing in the ongoing clinical program has been suspended pending further review of the SHIELD-1 results," sending its shares down by almost half that day.

Glaxo inked a $1.5 billion deal--$63.5 million upfront--with ChemoCentryx back in 2006 to explore new drugs for inflammatory bowel disease. At that time, vercirnon, or Traficet-EN, was in Phase II/III studies.

GSK had a big program underway. The pharma giant's first trial recruited 608 patients and tested two 500 mg doses--once and twice daily--for moderate to severe Crohn's. The primary endpoint focused on a score of at least 100 points at 12 weeks on the Crohn's Disease Activity Index. Clinical remission (CDAI score less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.

Shares of ChemoCentryx tanked again a few days ago after the biotech released weak interim results for its mid-stage study on a new drug for diabetic nephropathy. The company says the chemokine receptor CCX140 spurred a significant reduction in proteinuria after 12 weeks of therapy, spurring some confident remarks from executives. But some analysts said the drug was not clearly better than a placebo, prompting a 23% plunge in the stock price.

ChemoCentryx did not immediately respond to a query from FierceBiotech.

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